SARS-CoV-2 One-Step RT-PCR Kit II, RdRp and N genes, IVD (MD0487)

Refrigerated package



For professional in-vitro diagnostic use only

Second Generation (II) of NZYTech SARS-CoV-2 kits – Different targets in Different channels

Triple target assay (SARS-CoV-2, RdRp and N genes, and human RP gene)

Positive control to validate assay included

Internal control to confirm extraction / inhibition included


High Sensitivity: Early virus detection and diagnosis, detects as low as 250 copies of viral RNA /mL (LoD) sample (equivalent to 5 copies per reaction)

Precision: Coefficient of variation (CV) < 3%, allowing reproducible test results

High Throughput: Up to 94 clinical samples (96-well plate); up to 382 clinical samples (384-well plate)

High Specificity: Proven by in silico analysis as well as wet lab testing

Flexibility: Assay validated on widely used qPCR instruments including ABI® 7500 FAST, ABI® QuantStudio™ 5, ABI® QuantStudio™ 6 Pro, Bio-Rad® CFX96

Fast Time: < 40 min from nucleic acid extraction to results (for some validated qPCR instruments).

Minimal Sample Input: As low as 2 μL sample needed



NZYTech SARS-CoV-2 One-Step RT-PCR Kit II, RdRp and N genes (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 genome, through common real-time PCR platforms. The virus RNA dependent RNA polymerase (RdRp) and the Nucleocapsid phosphoprotein (N) genes have previously been identified as highly specific markers for SARS-CoV-2. This NZYTech kit targets specific regions in the RdRp and N genes of SARS-CoV-2 genome to provide the highest sensitivity of detection. By using NZYTech SARS-CoV-2 One-Step RT-PCR Kit II, RdRp and N genes (IVD), RNA isolated and purified with a CE IVD extration system is retrotranscribed (RT) to cDNA and subsequently amplified by PCR, in a single reaction, using three highly specific primer/probe sets exploiting the so-called TaqMan® principle. During this process, the probes specifically anneal to two regions of the SARS-CoV-2 genome, namely RdRp (within the Orf1ab polyprotein gene) and N genes, in case the sample was extracted from an infected patient. An additional primers/probe set acts as an endogenous internal control to detect nucleic acids of the human ribonuclease P [RNase P gene (RP)], assessing sample quality. In addition, this internal control demonstrates that no reaction inhibition has occurred by PCR inhibitors potentially present in the clinical/environmental samples. To allow identifying the amplification of the three specific targets in a single reaction, SARS-CoV-2 (RdRp and N genes) and human RNase P specific probes are differently labelled, with HEX™, FAM™ and Cy5™ reporter dyes, respectively. Note that this panel contains a duplex assay in two distinct optical channels – HEX™ and FAM™ – to report performance of the two PCR assays for SARS-CoV-2 detection. In addition, they are provided in optimized concentrations to make sure amplification of human mRNA, even when present at very high concentrations, does not limit the efficiency of the SARS-CoV-2 primers/probe sets.



– NZYSupreme One-step RT-qPCR Master Mix, ROX

– SARS-CoV-2/RP primers/probe Mix II (HEX™, FAM™ and Cy5™ labelled)

– SARS-CoV-2 (RdRp & N genes)/RP Positive Control (1 x 104 copies/μL)

– No-Template Control


Storage conditions: -30°C to -15°C

Shipping conditions: Shipped with dry ice

IFU Batches List: Go to Page 



SARS-CoV-2 Variants
PT Instructions for Use
IT Instructions for Use
FR Instructions for Use
ES Instructions for Use
EN Instructions for Use
DE Instructions for Use
Declaration of Conformity
Certificate of Analysis MD04872YO021A
Certificate of Analysis MD04871ZN122A
Certificate of Analysis MD04871ZN121A
Certificate of Analysis MD04871YO011A

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